J&J Family of Companies Clinical Trial Manager (1 of 8) in San Diego, California
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical Trial Manager to be based in either Raritan, NJ Titusville, NJ Spring House, PA Los Angeles, CA or San Diego, CA
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science, wherever it might be found.
We discover and develop innovative medical solutions to address unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Visit http://www.JanssenRnD.com to learn more.
The Clinical Trial Manager is responsible for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials.
Responsibilities also include management of global vendors involved in site facing activities such as IVRS, Central Lab, ePRO, Imaging, Translation, Printing, Ancillary supplies and Meeting Planners.
This position leads the Study Management Team (SMT) and interfaces with stakeholders internal and external to Global Clinical Development Operations (GCDO) functions, such as Study Responsible Physician, Global Data Manager, Trial Supply Manager, CRO staff, vendor staff and Study Sites (if applicable).
He/she works closely with the GCDO Trial Leader (GTL) and is member of the Trial Team, led by the GTL. Can contribute to taskforces and provide innovative input.
Ensure regional/global clinical operations deliverables progress per agreed upon timelines and milestones as leader of the Study Management Team (SMT).
This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor set up activities as assigned by the GTL. Support GTL in leading related CRO country & site activities.
leads the SMT, drives issue resolutions, and provides updates to all Trial Team members on the deliverable status.
Ensures required reports are generated and available for real time tracking of trial status.
Manages timely and accurate documentation, communication of study progress and issue escalation.
Site selection, enrollment, monitor study progress.
Contribute to data collection to support the site selection process
Establish enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level. Ensures the availability of robust recruitment/contingency plans are in place for each region.
Ensures timely and accurate documentation and communication of study progress and issue escalation.
Set-up country budgets and monitor actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend
Supports team by monitoring budgets and expenditures as expected by planned trial budget. Ensures availability of required reports to support real time tracking of trial status according to trial plan.
Creates and updates study-specific documents such as Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents.
Provides input into cross functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan.
Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed.
Set-up and coordination of Investigator Meetings.
Act as the primary contact person for the local teams within GCDO. Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit.
Demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledge.
Ensure compliance with global Health Authority regulations and guidelines and internal operating procedures and processes.
Participate in preparation for, and conduct of, Health Authority inspections and internal audits.
Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness.
Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
Coordinate data cleaning with some supervision towards a timely and successful database lock
Bachelor degree required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy)
Minimum of 6 years’ clinical trial management experience in the pharmaceutical industry or CRO is required.
2 years of global project management experience is preferred.
Requires clinical research operational knowledge, strong project planning/management and excellent communication skills
Should be flexible and have experience and ability in running global or regional teams in a virtual environment.
Consistent track record in successfully running trials from start-up to database lock is required
Experience with supervision of CROs/vendors is preferred.
Experience in GCP and ICH Guidelines is required.
Ability to operate with limited day to day supervision is required
Coach and mentor junior staff as needed is required.
Independent decision-making skills are essential to this role as are analytical skills and effectiveness in seeking solutions to issues.
Effective leadership and delegation skills and validated ability to foster team productivity and cohesiveness is required.
Computer literacy is also required.
Ability to work independently.
Commutable within 3-hour drive to the following locations: Spring House, PA, Raritan, NJ, Titusville, NJ, Los Angeles,CA is preferred
Willing to travel up to 20% of time is required.
Johnson & Johnson is an equal opportunity employer
United States-New Jersey-Raritan
North America-United States-California-San Diego, North America-United States-Pennsylvania-Spring House, North America-United States-California-Los Angeles, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)
Clinical Trial Coordination